PO-062 : Safety and Effectiveness of Daclatasvir and Asunaprevir in the Routine Clinical Practice in Korea: Interim Results of Post Marketing Surveillance

Aims: The objectives of this post marketing surveillance (PMS) are to describe the safety and effectiveness of the combination of Daclatasvir and Asunaprevir (DCV+ASV) for the treatment of chronic hepatitis C genotype 1b patients in real world practice in Korea. We report the interim findings of PMS to improve the understanding on safety and effectiveness of DCV+ASV in routine clinical setting. Methods: : Adult patients who were diagnosed with HCV genotype 1b infection with compensated liver disease and started DCV+ASV combination were enrolled. Patient background, administration status, concomitant medication, and measures of safety, efficacy, and pre-treatment NS5A resistance-associated substitutions (RASs) were collected for analysis. The risk factors associated with adverse events (AEs) and factors affecting effectiveness were analysed. This report includes data collected from October 2015 to December 2016. Results: From 182 patients registered, 177 patients (female, n=102 [57.63%]; mean age, 59.6 years [range: 32-85]; compensated cirrhosis, n=69 [40.0%]; treatment-experienced, n=57[32.2%]) were included in the safety analysis. 9 patients out of 169 patients terminated DCV+ASV treatment due to adverse events (n=2), virological breakthrough (VBT, n=4), economic reason (n=2) and withdrawal the consent (n=1), 8 patients were missed to follow up. Total 97 AEs were reported in 50 subjects (28.25%) and 20 Serious AEs were reported in 13 subjects (7.34%) regardless of causality, including 1 death due to progression of underlying hepatocellular carcinoma. Liver enzyme elevation were reported in 3 subjects (1.69%). Data for virological responses were available in 135 patients, SVR12 were confirmed in 127 patients (94.1%), except for 4 VBT, 2 relapsers and 2 patients with detectable HCV RNA at week 24. Pre-treatment NS5A RAS had been done in 170 patients and no pre-treatment RAS positivity on L31 either Y93 was observed. Conclusions: DCV+ASV was well tolerated and efficacious from this first interim analysis in Korean real-world practice.